Collapsible artificial ventricle and pumping shell

Abstract

An artificial ventricle for use as part of a total artificial heart for implantation within a living being as part of its circulatory system. The ventricle includes a soft and flexible blood pumping sac which can be collapsed to the substantially flattened, squeezed or rolled-up structure of much reduced size. The sac includes inlet and outlet ports to permit the flow of blood therethrough and is contained within a semi-rigid and removable enclosure which provides pumping means for driving blood flow through the ventricle. The semi-rigid shell includes open and closed configurations to allow emplacement of the shell around an attached ventricle already sutured in place as part of the circulatory system. Removal of the rigid shell is likewise feasible without disturbing the attached ventricle.

I claim: 
     
       1. An artificial ventricle for use as part of a total artificial heart for implantation within a living being as part of its circulatory system, said ventricle comprising: a soft and flexible blood pumping sac having extended (diastolic) and contracted (systolic) configurations and wall structure sufficient in size to develop adequate stroke volume for sustaining life within the living being, said blood sac having sufficient flexibility to collapse to a substantially flattened, squeezed or rolled up soft structure of reduced size to facilitate surgical implantation within restricted space of the chest cavity of the living being;   an inlet port positioned within the wall structure and having means for attachment to the atrium or other soft tissue of the circulatory system to form a continuous flow line therewith, said inlet port including means for receiving a oneway valve;   an outlet port positioned within the wall structure and having means for attachment to the aorta, pulmonary artery or other soft tissue of the circulatory system to form a continuous flow line therewith, said outlet port including means for receiving a one-way valve;   a semi-rigid shell structurally separable from the blood pumping sac and having closure means for developing closed and open configurations respectively permitting insertion around and removal from the blood pumping sac in situ with the circulatory system;   said closure means and shell providing a closed shell configuration slightly larger in shape and size at an interior surface than the extended configuration of the wall structure of the blood pumping sac and being structured to totally enclose the sac;   said shell including an opening for the inlet and outlet ports and sealing means to provide a circumferential seal at respective junctures of the shell with the inlet and outlet ports;   said closure means and shell further providing an open configuration enabling insertion of the contracted sac through a shell opening and removal of the shell from around the sac without affecting attachment of the sac as part of the circulatory system; and   pump means coupled through the rigid shell to enable alternating extension and collapse of the blood pumping sac in recurring pumping manner when the shell is in the closed configuration to allow inflow and expulsion of blood from the blood sac.   
     
     
       2. An artificial ventricle as defined in claim 1, wherein the blood sac comprises a thin walled structure of silicone. 
     
     
       3. An artificial ventricle as defined in claim 1, wherein the inlet and outlet ports are of semi-rigid construction and are interconnected by a bridging structure which maintains the respective ports in relatively fixed positions during surgical implantation. 
     
     
       4. An artificial ventricle as defined in claim 3, wherein the semi-rigid construction of the ports and interconnecting bridge structure provides a sealing situs for operation of the sealing means with the shell. 
     
     
       5. An artificial ventricle as defined in claim 4, wherein the sealing means further comprises a skirt member integrally formed at one end of the shell corresponding to the position of the ports of the blood sac, said skirt including an opening which geometrically conforms to the exterior construction of the ports and interconnecting bridge structure at the sealing situs to provide a contact juncture which assists in sealing the interior of the shell with respect to the enclosed blood sac. 
     
     
       6. An artificial ventricle as defined in claim 1, wherein the blood sac is prepared by a vacuum forming process. 
     
     
       7. An artificial ventricle as defined in claim 1, wherein the blood sac is prepared by a solution casting process. 
     
     
       8. An artificial ventricle as defined in claim 6, wherein the blood sac is formed from a composition of thermo-setting elastomers. 
     
     
       9. An artificial ventricle as defined in claim 7, wherein the blood sac is formed from a composition of thermo-setting elastomers. 
     
     
       10. An artificial ventricle as defined in claim 7, wherein the blood sac is formed from a composition of silicone. 
     
     
       11. An artificial ventricle as defined in claim 1, wherein the pump means includes (i) a fluid drive sac formed integrally with an interior surface of the shell, said drive sac having flexible structure and sufficient volume during expansion within the shell in the closed configuration to develop the desired stroke volume for the ventricle, and (ii) a fluid drive line for delivering fluid to extend and contract the drive sac during pumping action. 
     
     
       12. An artificial ventricle as defined in claim 1, wherein the blood sac further includes a stiff positioning ring having two openings for receiving the respective one-way valves, said ring openings being operable to maintain the one-way valves in proper alignment with respect to attached soft tissue. 
     
     
       13. An artificial heart comprising a pair of artificial ventricles as defined in claim 1, wherein the respective blood sacs correspond to left and right ventricles of the artificial heart and the respective shells enclosing each ventricle are joined at a common wall which divides the artificial heart into left and right ventricle sections. 
     
     
       14. An artificial heart as defined in claim 13, further comprising a single positioning ring coupled to the respective blood sacs and having four openings for receiving the one-way valves associated with each respective ventricle to thereby maintain the valves in proper alignment with attached soft tissue of the circulatory system. 
     
     
       15. An artificial heart as defined in claim 13 in which the common wall between the ventricles has an arcuate waveform cross-section waveform which positions the respective ports in a preferred physiological position for attachment within the chest cavity. 
     
     
       16. An artificial ventricle for use as part of a total artificial heat for implantation within a living being as part of its circulatory system, said ventricle comprising: a soft and flexible blood pumping sac having extended (diastolic) and contracted (systolic) configurations and wall structure sufficient in size to develop adequate stroke volume for sustaining life within the living being, said blood sac having sufficient flexibility to collapse to a substantially flattened, squeezed or rolled up soft structure of reduced size to facilitate surgical implantation within restricted space of the chest cavity of the living being;   an inlet port positioned within the wall structure and having means for attachment to the atrium or other soft tissue of the circulatory system to form a continuous flow line therewith, said inlet port including means for receiving a one-way valve;   an outlet port positioned within the wall structure and having means for attachment to the aorta, pulmonary artery or other soft tissue of the circulatory system to form a continuous flow line therewith, said outlet port including means for receiving a one-way valve;   a semi-rigid shell structurally separable from the blood pumping sac and having closure means for developing closed and open configurations respectively permitting insertion around and removal from the blood pumping sac in situ with the circulatory system;   said shell comprising two shell components which are configured to join at each shell periphery to form a closed configuration;   said closure means including a connecting hinge element disposed at one edge of the joining peripheries to form a clamshell configuration capable of opening to permit insertion of the blood sac and enclosing around the blood sac to form a confining shell structure to limit expansion and displacement of the blood sac in response to operation of a pumping means;   said closure means and shell providing a closed shell configuration slightly larger in shape and size at an interior surface than the extended configuration of the wall structure of the blood pumping sac and being structured to totally enclose the sac;   said shell including an opening for the inlet and outlet ports and sealing means to provide a circumferential seal at respective junctures of the shell with the inlet and outlet ports;   said closure means and shell further providing an open configuration enabling insertion of the contracted sac through a shell opening and removal of the shell from around the sac without affecting attachment of the sac as part of the circulatory system; and   pumping means coupled through the rigid shell to enable alternating extension and collapse of the blood pumping sac in recurring pumping manner when the shell is in the closed configuration to allow inflow and expulsion of blood from the blood sac.   
     
     
       17. An artificial ventricle as defined in claim 16, wherein the connecting hinge element comprises a bridging section of shell wall structure integral with each of the shell components and forming a continuous shell wall therwith which flexes at the bridging section to provide hinge action to facilitate opening and closing the shell structure. 
     
     
       18. An artificial ventricle as defined in claim 16, wherein the periphery of the respective shell component includes a tongue and groove attachment structure to provide a tight seal when the shell components are positioned in the closed configuration. 
     
     
       19. An artificial ventricle as defined in claim 16, further comprising latch means coupled near the shell opening for secure fastening of the respective shell components in sealed configuration around the inlet and outlet ports.